Back Pain

A Phase 3 Randomized Clinical Trial Investigating the Efficacy and Safety of a Lumbar Injection in the Treatment of Pain associated with Back and Leg pain.

1. Participants:

• Inclusion Criteria: Adults (18-70 years old) with a primary diagnosis of lumbar and/or lumbosacral radiculopathy that have radicular pain symptoms in the current episode that have been present for at least 8 weeks but not longer than 9 months. Subjects must also have had no significant improvement following a minimum of 8 weeks of a) mechanical intervention (physical therapy, heat therapy/massage, or chiropractic treatment AND b) over-the-counter analgesics (NSAIDs, topical patches/creams/ointments)
• Exclusion Criteria: Individuals that have significant pain unrelated to lumbosacral radiculopathy, diagnosis of fibromyalgia, history of lumbar surgery, active infection, or have received an epidural steroid injection, nerve block, or similar procedure in the lumbosacral area 8 weeks prior to screening. 

2. Randomization:

• Participants will be randomly assigned to a treatment group or a control group.